FDA.report

N/A

Primary DI
04262494463877
Brand
N/A
Company
Doppkon GmbH & Co. KG
Model
A-100-791
Catalog number
A-100-791
Device description
Hook Probe PH D 3.0mm WL 150mm
Published
2025-09-12
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

Product Codes

CodeName
HXBProbe

Product Code Classifications

CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04262494463877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04262494463877042624944638774262494463877

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
314157821
Device count
1
DM exempt
true
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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