FDA.reportPublic FDA data

N/A

Primary DI
B58206536600
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
0653660
Catalog number
0653660
Device description
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B58206536600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. 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
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10080196320493MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-04
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26
00190776427641MillenniumAvalign Technologies, Inc.MDM2026-08-26
00810158217409PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
00850088713626PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
04054462913602evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913619evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913626evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913909evonosevonos GmbH & Co. KGMDM2026-08-25
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04054462913923evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913947evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913978evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913985evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913992evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914364evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914388evonosevonos GmbH & Co. KGMDM2026-08-25
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04054462914845evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914852evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914906evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914975evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914982evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914999evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915002evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915019evonosevonos GmbH & Co. KGMDM2026-08-25