FDA.reportPublic FDA data

Scalpel handle

Primary DI
04250676713780
Brand
Scalpel handle
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-360-33
Catalog number
10-360-33
Device description
no. 3L 21 cm
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676713780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676713780042506767137804250676713780

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050659354647Brünings anastignatic aural magnifier10-180-0010-180-002026-01-21
04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04250676747211Tray set with flex band1000617-31000617-32025-12-03
04250676747235Filter modul with 8 x LM10-845-0110-845-012025-12-03
04250676747228Tray set1000617-3-01000617-3-02025-12-03
04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03
04251993601927Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04251993601934Tray set with flex band1000617-31000617-32025-12-03
04250381821503Gillies skin hook6-1240/186-1240/182025-09-29
04250676710017Hook85-900-0185-900-012025-09-29
04250676711625ForkAHA-0147AHA-01472025-09-29
04250676716880ENT-single-use suction tubes, angled301302030130202025-09-29
04250676716897ENT-single-use suction tubes, angled301303030130302025-09-29
04250676731982Salivary duct probe40-611-0040-611-002025-09-29
04250676731999Salivary duct probe40-611-0140-611-012025-09-29
04250676732002Salivary duct probe40-611-0240-611-022025-09-29
04250676732026Salivary duct probe40-611-0440-611-042025-09-29
04250676732033Salivary duct probe40-611-0540-611-052025-09-29
04250676740625Bowman salivary duct probe40-609-4040-609-402025-09-29
04250676740632Bowman salivary duct probe40-609-0040-609-002025-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381863572Scalpel handleSpiggle & Theis Medizintechnik GmbHGES2025-09-24
06938535542884Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542891Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542914Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542945Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542969Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542976Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542983Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543003Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543010Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543027Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543034Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543041Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543058Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543065Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543072Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543089Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543096Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543102Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543119Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543126Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543133Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543232Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543249Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543263Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543294Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543317Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543324Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543331Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543355Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05