FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197022675
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
100-850-007
Catalog number
100-850-007
Device description
"Hook 250mm, 10"", sharp "
Published
2024-06-21
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
GDNKNIFE, AMPUTATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDNKnife, AmputationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197022675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197022675040491970226754049197022675

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746294700info@rz-medizintechnik.com

Regulatory Flags#

DUNS number
312953227
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049197152594RZ Medizintechnik GmbH250-035-180250-035-1802024-10-16
04049197152624RZ Medizintechnik GmbH250-035-300250-035-3002024-10-16
04049197152648RZ Medizintechnik GmbH250-037-000250-037-0002024-10-16
04049197152662RZ Medizintechnik GmbH250-039-000250-039-0002024-10-16
04049197152679RZ Medizintechnik GmbH250-040-000250-040-0002024-10-16
04049197152686RZ Medizintechnik GmbH250-041-000250-041-0002024-10-16
04049197152693RZ Medizintechnik GmbH250-042-000250-042-0002024-10-16
04049197152723RZ Medizintechnik GmbH250-044-000250-044-0002024-10-16
04049197152747RZ Medizintechnik GmbH250-045-000250-045-0002024-10-16
04049197152754RZ Medizintechnik GmbH250-048-000250-048-0002024-10-16
04049197152761RZ Medizintechnik GmbH250-048-180250-048-1802024-10-16
04049197152778RZ Medizintechnik GmbH250-048-230250-048-2302024-10-16
04049197152785RZ Medizintechnik GmbH250-048-300250-048-3002024-10-16
04049197152860RZ Medizintechnik GmbH250-053-180250-053-1802024-10-16
04049197152877RZ Medizintechnik GmbH250-054-180250-054-1802024-10-16
04049197390668RZ Medizintechnik GmbH250-035-230250-035-2302024-10-16
04049197390675RZ Medizintechnik GmbH250-038-000250-038-0002024-10-16
04049197390729RZ Medizintechnik GmbH250-051-000250-051-0002024-10-16
04049197390743RZ Medizintechnik GmbH250-052-000250-052-0002024-10-16
04049197390750RZ Medizintechnik GmbH250-053-230250-053-2302024-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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24026704941647PILLINGTELEFLEX INCORPORATEDGDN2026-03-23
14026704941657PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
24026704941654PILLINGTELEFLEX INCORPORATEDGDN2026-02-11
08403207009500Anmuth Medical InternationalAnmuth Medical International, LLCGDN2025-06-09
00840343725563GEN2SURGIX MEDICAL LLCGDN2025-02-11
B356EE173000American MedicalsAmerican MedicalsGDN2024-11-12
04049197022613RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022637RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022644RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022651RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197022668RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
04049197410540RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDN2024-06-21
B356126CL120American MedicalsAmerican MedicalsGDN2024-05-14
G586N91281280Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
G586N91281310Novo SurgicalNOVO SURGICAL, INC.GDN2023-12-18
00190776062033AvalignAvalign Technologies, Inc.GDN2023-09-28
00190776289218MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
00190776343408MILLENNIUMAvalign Technologies, Inc.GDN2023-09-28
B356BH420280American MedicalsAmerican MedicalsGDN2023-09-28
00810123205929Adler Instrument CompanyAdler, Inc.GDN2023-06-16
00842962107140HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842962160565HNM MedicalHNM STAINLESS, LLC.GDN2023-02-15
00842331143984Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-11
00842331134623Novo Surgical Inc. NOVO SURGICAL, INC.GDN2022-11-10
B35607423200American MedicalsAmerican MedicalsGDN2022-09-21
B35607423240American MedicalsAmerican MedicalsGDN2022-09-21
B356BH420130American MedicalsAmerican MedicalsGDN2022-09-16
B356BH432220American MedicalsAmerican MedicalsGDN2022-09-16