FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517112490
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
NEE0012T
Device description
Castro Ndl Hldr, TJ, Hvy, Str, TC, 18cm
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517112490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517112490008425171124908425171124900842517112490

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags#

DUNS number
101070070
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
G453230117BCL0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
G453230117BCR0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
00192896106833Matthieu Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-02-26
B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
D928301140LH0NEEDLE HOLDER MAYO-HEGAR 7" LEFT HAND TCW.H. Holden, Inc.FHQ2026-01-05
D9283011450NEEDLE HOLDER MAYO-HEGAR 8" / 20CM TCW.H. Holden, Inc.FHQ2026-01-05
D9283011510NEEDLE HOLDER OLSEN-HEGAR 4 1/2" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011570NEEDLE HOLDER OLSEN-HEGAR 7 1/4" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011600NEEDLE HOLDER RYDER 5 1/8" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011640NEEDLE HOLDER FRENCH RYDER 9" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011650NEEDLE HOLDER HEANEY 8 1/4" - 20CMW.H. Holden, Inc.FHQ2026-01-05
D928301173OS0NEEDLE HOLDER MINI-RYDER 6" SM OFF SET HANDLEW.H. Holden, Inc.FHQ2026-01-05
D92830117470NEEDLE HOLDER MINI-RYDER 7" TC NEW PATTERNW.H. Holden, Inc.FHQ2026-01-05
D928301174D0NEEDLE HOLDER MINI-RYDER 7" DELICATE, TC SERRATEDW.H. Holden, Inc.FHQ2026-01-05