FDA.report

ORTHOMED

Primary DI
B8035207710
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 52-0771
Device description
WILTSE GELPI RETRACTOR 11"
Published
2023-11-15
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

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B8035207710PrimaryHIBCC0

GMDN Terms

TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
086618626
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B8035200860ORTHOMEDOM 52-00862026-02-18
B8035200870ORTHOMEDOM 52-00872026-02-18
B8035200880ORTHOMEDOM 52-00882026-02-18
B8035200900ORTHOMEDOM 52-00902026-02-18
B8035200920ORTHOMEDOM 52-00922026-02-18
B8035200930ORTHOMEDOM 52-00932026-02-18
B8035200940ORTHOMEDOM 52-00942026-02-18
B8035201160ORTHOMEDOM 52-01162026-02-18
B8035201180ORTHOMEDOM 52-01182026-02-18
B8035201220ORTHOMEDOM 52-01222026-02-18
B8035201240ORTHOMEDOM 52-01242026-02-18
B8035201280ORTHOMEDOM 52-01282026-02-18
B8035201300ORTHOMEDOM 52-01302026-02-18
B8035201980ORTHOMEDOM 52-01982026-02-18
B8035202020ORTHOMEDOM 52-02022026-02-18
B8035202040ORTHOMEDOM 52-02042026-02-18
B8035202060ORTHOMEDOM 52-02062026-02-18
B8035105300ORTHOMEDOM 51-05302026-02-09
B8035105320ORTHOMEDOM 51-05322026-02-09
B8035105340ORTHOMEDOM 51-05342026-02-09

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