FDA.report

Innomed, Inc.

Primary DI
00840277102126
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
1805
Catalog number
1805
Device description
Shereff Ankle Distractor
Published
2020-07-20
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
HSTApparatus, Traction, Non-Powered
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840277102126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277102126008402771021268402771021260840277102126

GMDN Terms

TermDefinition
Surgical traction tensionerA hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis), typically during orthopaedic procedures (e.g., cervical spine surgery, pelvic reconstruction, fracture reduction). It may be a floor-standing pole or attached to an operating table or table extension, and typically consists of a multi-jointed structure with metal bars/posts, a manual screw/crank for traction adjustment, and mounting clamps/adaptors.

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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00840277133205Innomed, Inc.4095-EU4095-EU2026-02-06
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00840277133250Innomed, Inc.117311732026-02-06
00840277133267Innomed, Inc.T1018-KTT1018-KT2026-02-06
00840277133274Innomed, Inc.T1019-KTT1019-KT2026-02-06
00840277133281Innomed, Inc.T1020-KTT1020-KT2026-02-06
00840277133298Innomed, Inc.T1021-KTT1021-KT2026-02-06
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