FDA.reportPublic FDA data

REMA Endo Retractors

Primary DI
04059223112447
Brand
REMA Endo Retractors
Company
DEWIMED Medizintechnik GmbH
Model
29-033-760
Device description
Oesophageal retractor for gastric banding 10mm x 430mm with hole for thread at the tip of the mouth
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059223112447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059223112447040592231124474059223112447

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held endoscopic retractor, reusableA hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter
Shaft Length430Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
343472288
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059223159886REMA Shaver Blades15-6143015-614302025-02-27
04059223159893REMA Shaver Blades15-6158015-615802025-02-27
04059223160028REMA Shaver Blades15-6144015-614402025-02-27
04059223160035REMA Shaver Blades15-6151015-615102025-02-27
04059223160059REMA Shaver Blades15-6152015-615202025-02-27
04059223160073REMA Shaver Blades15-6153015-615302025-02-27
04059223160103REMA Shaver Blades15-6154015-615402025-02-27
04059223160127REMA Shaver Blades15-6156015-615602025-02-27
04059223160523REMA Shaver Blades15-6151515-615152025-02-27
04059223160899REMA Shaver Blades15-6143115-614312025-02-27
04059223160905REMA Shaver Blades15-6144115-614412025-02-27
04059223164873REMA Shaver Blades15-6221015-622102025-02-27
04059223166303REMA Shaver Blades15-6148015-614802025-02-27
14035282341599REMA Shaver Blades15-6143015-614302025-02-27
14035282341841REMA Shaver Blades15-6158015-615802025-02-27
14035282341636REMA Shaver Blades15-6144015-614402025-02-27
14035282341711REMA Shaver Blades15-6151015-615102025-02-27
14035282341766REMA Shaver Blades15-6152015-615202025-02-27
14035282341780REMA Shaver Blades15-6153015-615302025-02-27
14035282341803REMA Shaver Blades15-6154015-615402025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267896Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-25
00190776432379MillenniumAvalign Technologies, Inc.GDG2026-09-24
00190776432423MillenniumAvalign Technologies, Inc.GDG2026-09-24
00724995267483Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267490Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267506Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267513Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267520Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267544Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267551Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267568Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267575Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267582Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267599Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267605Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267612Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267629Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00850088713954PRINCETONPrinceton Medical Group, Inc.GDG2026-09-22
00190776431099MillenniumAvalign Technologies, Inc.GDG2026-09-21
B033K941409" Nerve HookKapp Surgical Instrument Co.GDG2026-08-27
00810158215955PRINCETONPrinceton Medical Group, Inc.GDG2026-08-25
10850067560323MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560330MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560347MaxRetractSurgical Principals, IncGDG2026-08-25
00190776419660MillenniumAvalign Technologies, Inc.GDG2026-08-23
00190776417161MillenniumAvalign Technologies, Inc.GDG2026-08-19
00190776417079MillenniumAvalign Technologies, Inc.GDG2026-08-18
00190776422219MillenniumAvalign Technologies, Inc.GDG2026-07-31
00190776407346MillenniumAvalign Technologies, Inc.GDG2026-07-28
B382SD907072080Surgical DirectSurgical Direct, Inc.GDG2026-07-27