FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197418973
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
170-800-312
Catalog number
170-800-312
Device description
Rectal Blade, large 23x98mm
Published
2024-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197418973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197418973040491974189734049197418973

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. 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
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049197177603RZ Medizintechnik GmbH253-000-097253-000-0972025-09-22
04049197393393RZ Medizintechnik GmbH253-000-084253-000-0842025-09-22
04049197495325RZ Medizintechnik GmbH253-000-320253-000-3202025-09-22
04049197495387RZ Medizintechnik GmbH253-000-332253-000-3322025-09-22
04049197177368RZ Medizintechnik GmbH253-000-044253-000-0442025-07-30
04049197177467RZ Medizintechnik GmbH253-000-047253-000-0472025-07-30
04049197177580RZ Medizintechnik GmbH253-000-094253-000-0942025-07-30
04049197177801RZ Medizintechnik GmbH253-000-200253-000-2002025-07-30
04049197178082RZ Medizintechnik GmbH253-000-201253-000-2012025-07-30
04049197178150RZ Medizintechnik GmbH253-000-210253-000-2102025-07-30
04049197178167RZ Medizintechnik GmbH253-000-211253-000-2112025-07-30
04049197178501RZ Medizintechnik GmbH253-000-258253-000-2582025-07-30
04049197178563RZ Medizintechnik GmbH253-000-352253-000-3522025-07-30
04049197178570RZ Medizintechnik GmbH253-000-356253-000-3562025-07-30
04049197178723RZ Medizintechnik GmbH253-000-358253-000-3582025-07-30
04049197178730RZ Medizintechnik GmbH253-000-366253-000-3662025-07-30
04049197178747RZ Medizintechnik GmbH253-000-368253-000-3682025-07-30
04049197178822RZ Medizintechnik GmbH253-000-524253-000-5242025-07-30
04049197178839RZ Medizintechnik GmbH253-000-527253-000-5272025-07-30
04049197178846RZ Medizintechnik GmbH253-000-552253-000-5522025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811023018INKAThe Trustee for KAISER FAMILY TRUSTFGN2026-03-16
B382SD1471020010Surgical DirectSurgical Direct, Inc.FGN2026-02-16
B382SD934117790Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117800Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117810Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117820Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117830Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD711510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD722510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD914781140Surgical DirectSurgical Direct, Inc.FGN2025-07-23
B382SD914173650Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810000Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417811010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD9141801050Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD4834150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861300Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861400Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4862150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4871160Surgical DirectSurgical Direct, Inc.FGN2025-07-02
00810123209361Adler Instrument CompanyAdler, Inc.FGN2025-05-23
B382SD147091530Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691000Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691010Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691020Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691030Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD1417812200Surgical DirectSurgical Direct, Inc.FGN2025-02-20
B382SD1417812310Surgical DirectSurgical Direct, Inc.FGN2025-02-20
00840319757611Hayden MedicalHayden Medical, Inc.FGN2025-01-10
00840319757628Hayden MedicalHayden Medical, Inc.FGN2025-01-10