FDA.report

Proximal Humerus Plating System

Primary DI
00841506138404
Brand
Proximal Humerus Plating System
Company
SKELETAL DYNAMICS L.L.C.
Model
Forceps, Gelpi Retractor
Catalog number
FRCP-GR
Device description
Forceps, Gelpi Retractor
Published
2025-12-01
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
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841506138404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506138404008415061384048415061384040841506138404

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

Contacts

PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags

DUNS number
869056148
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

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