FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8034701660
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 47-0166
Device description
"LOWMAN BONE CLAMP 8"" 1X1"
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HDXDilator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDXDilator, VaginalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8034701660PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8035903160ORTHOMEDOM 59-03162026-07-22
B8038600980ORTHOMEDOM 86-00982026-07-22
B8038600990ORTHOMEDOM 86-00992026-07-22
B803860120L0ORTHOMEDOM 86-0120L2026-07-22
B8038601250ORTHOMEDOM 86-01252026-07-22
B8039018420ORTHOMEDOM 90-18422026-07-22
B8039018430ORTHOMEDOM 90-18432026-07-22
B8039018840ORTHOMEDOM 90-18842026-07-22
B8039030020ORTHOMEDOM 90-30022026-07-22
B803903220010ORTHOMEDOM 90-3220-012026-07-22
B803903220020ORTHOMEDOM 90-3220-022026-07-22
B8039401000ORTHOMEDOM 94-01002026-07-22
B8039601360ORTHOMEDOM 96-01362026-07-22
B8039601370ORTHOMEDOM 96-01372026-07-22
B8039601390ORTHOMEDOM 96-01392026-07-22
B8039601400ORTHOMEDOM 96-01402026-07-22
B803NL97010ORTHOMEDOM NL97012026-07-22
B803NL9701H0ORTHOMEDOM NL9701-H2026-07-22
B803PW12A0ORTHOMEDOM PW-12A2026-07-22
B803PW14G0ORTHOMEDOM PW-14G2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494460791N/ADoppkon GmbH & Co. KGHDX2025-09-10
00810142352307Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00850005838029Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838036Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838043Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838050Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838067Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838074Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838081Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838098Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838104Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838111Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838128Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00860012225002Hope&Her Vaginal DilatorsLUJENA, INC.HDX2024-11-15
04719894432236BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432243BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432250BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432267BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432274BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432281BiotequeBioteque Taiwan Ltd.HDX2024-04-08