FDA.reportPublic FDA data

Innomed, Inc.

Primary DI
00840277121134
Brand
Innomed, Inc.
Company
INNOMED, INC.
Model
1829
Catalog number
1829
Device description
HFD Small Bone Spreader
Published
2020-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840277121134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840277121134008402771211348402771211340840277121134

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
878427491
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840277132505Innomed, Inc.3009-R-D3009-R-D2026-04-24
00840277133618Innomed, Inc.4090-EXT24090-EXT22026-04-21
00840277133458Innomed, Inc.392239222026-04-17
00840277133465Innomed, Inc.2056-012056-012026-04-17
00840277133472Innomed, Inc.2056-022056-022026-04-17
00840277133489Innomed, Inc.2056-032056-032026-04-17
00840277133496Innomed, Inc.2056-042056-042026-04-17
00840277133502Innomed, Inc.2056-062056-062026-04-17
00840277133519Innomed, Inc.2056-072056-072026-04-17
00840277133526Innomed, Inc.2056-082056-082026-04-17
00840277133533Innomed, Inc.2056-052056-052026-04-17
00840277133540Innomed, Inc.2056-092056-092026-04-17
00840277133557Innomed, Inc.2056-102056-102026-04-17
00840277133564Innomed, Inc.2056-112056-112026-04-17
00840277133571Innomed, Inc.2056-122056-122026-04-17
00840277133588Innomed, Inc.2056-132056-132026-04-17
00840277133595Innomed, Inc.2056-142056-142026-04-17
00840277133601Innomed, Inc.2056-152056-152026-04-17
00840277132499Innomed, Inc.3009-L-D3009-L-D2025-07-03
00840277132185Innomed, Inc.3001-D3001-D2025-05-07

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Primary DI, Brand, Company table
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00810118343124StieberAutomated Medical Products Corp.GAD2026-05-28
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00810118343155StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343162StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343179StieberAutomated Medical Products Corp.GAD2026-05-28
04052536085552neon3Ulrich GmbH & Co. KGLXH2026-05-28
M7403030028Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030029Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
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00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
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07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
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07613327007558XIA 3Stryker CorporationLXH2019-11-25