FDA.report

X-PAC

Primary DI
00850041805559
Brand
X-PAC
Company
EXPANDING INNOVATIONS, INC.
Model
EI3201
Device description
X-PAC N-GAGE Plate and Coupler Caddy
Published
2025-09-19
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
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K250602000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250602000X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20KWQ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850041805559PrimaryGS10

GMDN Terms

TermDefinition
Surgical instrument interim-placement holder, reusableA device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. 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
false
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
00810166520126X-PACEI38602025-09-24
00810166520133X-PACEI38612025-09-24
00810166520140X-PACEI38622025-09-24
00810166520157X-PACEI38632025-09-24
00810166521147X-PACEI38752025-09-24
00810166521567X-PACEI39222025-09-23
00810166521697X-PACEI39252025-09-23
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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