FDA.report

Innomed, Inc.

Primary DI
00840277117489
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
4208-00
Catalog number
4208-00
Device description
Locking Joint Compressor/Distractor Set
Published
2021-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRetractor
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277117489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277117489008402771174898402771174890840277117489

GMDN Terms

TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
878427491
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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00840277133281Innomed, Inc.T1020-KTT1020-KT2026-02-06
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