FDA.reportPublic FDA data

N/A

Primary DI
B5821051210TW0
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
1051210TW
Catalog number
1051210TW
Device description
HOLDER, NEEDLE, GASTROENTEROLOGIC
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B5821051210TW0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
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

Contacts#

Phone, Email table
PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags#

DUNS number
107043630
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B58208011750N/A080117508011752020-09-24
B58208011770N/A080117708011772020-09-24
B58208011810N/A080118108011812020-09-24
B58208012000N/A080120008012002020-09-24
B58208012050N/A080120508012052020-09-24
B58208012120N/A080121208012122020-09-24
B58208012130N/A080121308012132020-09-24
B58208012160N/A080121608012162020-09-24
B582081899N/A0818990818992020-09-24
B58208349610N/A08349610083496102020-09-24
B5820834962N/A083496208349622020-09-24
B5820834963N/A083496308349632020-09-24
B5820834964N/A083496408349642020-09-24
B5820834965N/A083496508349652020-09-24
B5820834966N/A083496608349662020-09-24
B5820834968N/A083496808349682020-09-24
B582080140720N/A08014072080140722020-09-24
B582080141040N/A08014104080141042020-09-24
B582080BYRDCURETTE20N/A080BYRD CURETTE2080BYRD CURETTE22020-09-24
B582080BYRDCURETTE200N/A080BYRD CURETTE2/0080BYRD CURETTE202020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931517SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931678SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934709SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934716SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934723SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934921SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934938SURGIPROSSurgipros, LLCFHQ2026-07-28