FDA.report

X-PAC

Primary DI
00810166520126
Brand
X-PAC
Company
EXPANDING INNOVATIONS, INC.
Model
EI3860
Device description
Bayonet Pituitary, Straight, 2mm
Published
2025-09-24
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
HTXRongeur

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810166520126PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
650 861 3129mmuthini@expandinginnovations.com

Regulatory Flags

DUNS number
081309444
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00810166520003X-PACEI30572026-03-20
00810166521543X-PACEI39202025-06-05
00810166520102Expanding InnovationsEI38582025-09-24
00810166520133X-PACEI38612025-09-24
00810166520140X-PACEI38622025-09-24
00810166520157X-PACEI38632025-09-24
00810166521147X-PACEI38752025-09-24
00810166521567X-PACEI39222025-09-23
00810166521697X-PACEI39252025-09-23
00850041805559X-PACEI32012025-09-19
00850041805580X-PACXP02LPSCXP02LPSC2025-09-19
00850041805610X-PACXP0113LPXP0113LP2025-09-19
00850041805665X-PACXP0215LPXP0215LP2025-09-19
00850041805689X-PACXP0411LPXP0411LP2025-09-19
00850041805696X-PACXP0413LPXP0413LP2025-09-19
00850041805467X-PACEI3203EI32032025-09-18
00850041805474X-PACEI3204EI32042025-09-18
00850041805481X-PACEI3206EI32062025-09-18
00850041805504X-PACEI3208EI32082025-09-18
00850041805566X-PACEI3202EI32022025-09-18

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B382SD62240190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62241190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD91931609Surgical DirectSurgical Direct, Inc.HTX2026-02-10
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