FDA.reportPublic FDA data

Volkmann sharp spoon

Primary DI
04250381863534
Brand
Volkmann sharp spoon
Company
Spiggle & Theis Medizintechnik GmbH
Model
1-1555/01
Catalog number
1-1555/01
Device description
size 1 17 cm
Published
2025-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZESPOON, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZESpoon, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381863534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381863534042503818635344250381863534

GMDN Terms#

Term, Definition table
TermDefinition
Ear spoonA hand-held manual surgical instrument intended to be used during interventions in the ear to remove or manipulate tissue or anatomical structures. It is usually made of high-grade stainless steel and has a cylindrical handle located centrally from which a shaft protrudes in both directions. These shafts terminate with an operative instrument, one of which is spoon-shaped. The opposite tip may be, e.g., blunt or pointed and possibly at a right angle to the shaft. 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250676736000Fiberglass light carrier50-231-0150-231-012025-09-15
04250676736024Fiberglass light carrier50-231-0350-231-032025-09-15
04250676736031Fiberglass light carrier50-234-0150-234-012025-09-15
04250676736055Fiberglass light carrier50-234-0350-234-032025-09-15
04250381858387Fiberglass light carrier for rigid and50-205-1250-205-122022-09-27
04250381858394Fiberglass lightcarrier for rigid and50-205-3650-205-362022-09-27
04250381858400Fiberglass lightcarrier for rigid and50-205-7050-205-702022-09-27
04250381858509Fiberglass lightcarrier for laser50-217-1250-217-122022-09-27
04250381858516Fibreglass light carrier for laser50-217-3650-217-362022-09-27
04250381858523Fiberglass lightcarrier for laser50-217-7050-217-702022-09-27
04250676736048Fiberglass light carrier50-234-0250-234-022022-09-27
04250676701800Fibre light carrier20-155-0020-155-002022-09-14
04250676748188Endoragard teeth protector50-240-0050-240-002026-04-27
04250676748195Medasil teeth protector50-250-0050-250-002022-09-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381863497Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863503Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863510Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863527Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863541Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863558Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381868713Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
00840306823954Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JZE2025-01-17
00840183510701BR Surgical, LLCBR Surgical, LLCJZE2024-02-21
00311917136295WalgreensWALGREEN CO.JZE2022-02-18
10311917136292WalgreensWALGREEN CO.JZE2022-02-18
00079573109281Ezy DoseAPOTHECARY PRODUCTS, LLCJZE2020-10-16
10079573109288Ezy DoseAPOTHECARY PRODUCTS, LLCJZE2020-10-16
00681131395328EquateWAL-MART STORES, INC.JZE2020-09-21
20681131395322EquateWAL-MART STORES, INC.JZE2020-09-21
00023185002430EZY DOSEAPOTHECARY PRODUCTS, LLCJZE2020-08-24
10023185002437EZY DOSEAPOTHECARY PRODUCTS, LLCJZE2020-08-24