FDA.report

OT EQUATOR-OT BRIDGE

Primary DI
D821130RPS61
Brand
OT EQUATOR-OT BRIDGE
Company
RHEIN 83 SRL
Model
OT EQUATOR ReplaceSelect ø 6 h.1
Catalog number
130RPS61
Published
2020-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D821130RPS61PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
439240722
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
true
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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08059224167497PLUSTransfer Heli-Loc open044CAIP-HE2026-02-10
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08059224167541PLUSCap without pin black (lab use)140CPN-HE2026-02-10
08059224167558PLUSCap without pin pink (0,8kg / 1,76lbs)140CPP-HE2026-02-10
08059224167565PLUSCap with pin yellow (0,7kg / 1,54lbs)140CPPG-HE2026-02-10
08059224167572PLUSCap with pin black (lab use)140CPPN-HE2026-02-10
08059224167589PLUSCap with pin pink (0,9kg / 1,98lbs)140CPPP-HE2026-02-10

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