FDA.report

BEAR

Primary DI
B351B280010
Brand
BEAR
Company
Mytamed, Inc.
Model
2.80.01
Catalog number
2.80.01
Device description
Joseph Skin Hook, Single
Published
2021-06-01
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
B351B280010PrimaryHIBCC0

GMDN Terms

TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
015903922
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
B351B203020BEAR2.03.022.03.022020-06-10
B351B615050BEAR6.15.056.15.052020-06-10
B351B620120BEAR6.20.126.20.122020-05-28
B351B620130BEAR6.20.136.20.132020-05-28
B351B620140BEAR6.20.146.20.142020-05-28
B351B706270BEAR7.06.277.06.272020-05-12
B351B706280BEAR7.06.287.06.282020-05-12
B351B706290BEAR7.06.297.06.292020-05-12
B351B706300BEAR7.06.307.06.302020-05-12
B351B706310BEAR7.06.317.06.312020-05-12
B351B706320BEAR7.06.327.06.322020-05-12
B351B706340BEAR7.06.347.06.342020-05-12
B351B707260BEAR7.07.267.07.262020-05-12
B351B810100BEAR8.10.108.10.102020-05-19
B351B707270BEAR7.07.277.07.272020-05-12
B351B707290BEAR7.07.297.07.292020-05-12
B351B707300BEAR7.07.307.07.302020-05-12
B351B810050BEAR8.10.058.10.052020-05-19
B351B810060BEAR8.10.068.10.062020-05-19
B351B810070BEAR8.10.078.10.072020-05-19

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00841536147766ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147773ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147780ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00810158219298PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
00810158219342PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
M93074301120S0Life InstrumentsLife Instrument CorporationGAD2026-03-12