FDA.report

FENTEX

Primary DI
04250407708993
Brand
FENTEX
Company
FENTEX medical GmbH
Model
101402FX
Catalog number
101402FX
Device description
Retractor by Helms 11 cm, 2 prongs left, full blade right
Published
2022-12-07
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

Related Records

Contact Domains

Product Codes

CodeName
KALRETRACTOR, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250407708993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250407708993042504077089934250407708993

GMDN Terms

TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4974679496212s.renner@fentexmedical.com

Regulatory Flags

DUNS number
507221724
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
false
Sterilization required before use
true

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04250407786847FENTEX540730FX540730FX2025-03-25
04250407786854FENTEX540732FX540732FX2025-03-25
04250407786861FENTEX540733FX540733FX2025-03-25
04250407786878FENTEX540734FX540734FX2025-03-25
04250407786885FENTEX540701FX540701FX2025-03-25
04250407786892FENTEX540702FX540702FX2025-03-25
04250407786908FENTEX540704FX540704FX2025-03-25
04250407778262FENTEX540780FX540780FX2025-02-19
04250407786663FENTEX118960FX118960FX2024-12-28
04250407786670FENTEX118970FX118970FX2024-12-28
04250407786731FENTEX540725FX540725FX2024-10-18
04250407786748FENTEX540726FX540726FX2024-10-18
04250407786755FENTEX540727FX540727FX2024-10-18
04250407786762FENTEX540728FX540728FX2024-10-18
04250407731571FENTEX363600FX363600FX2022-12-12
04250407731816FENTEX379100FX379100FX2022-12-12
04250407785116FENTEX540700FX540700FX2024-08-01
04250407785314FENTEX540705FX540705FX2024-08-01
04250407785321FENTEX540710FX540710FX2024-08-01

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