FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250602000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041805559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041805559008500418055598500418055590850041805559

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
650 861 3129mmuthini@expandinginnovations.com

Regulatory Flags#

DUNS number
081309444
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810166522861Expanding InnovationsEI46242026-05-27
00810166522878Expanding InnovationsEI46252026-05-27
00810166522366X-PACEI24732026-05-27
00810166522373X-PACEI24742026-05-27
00810166522809X-PACEI46182026-05-27
00810166522816Expanding InnovationsEI46192026-05-27
00810166522823Expanding InnovationsEI46202026-05-27
00810166522830Expanding InnovationsEI46212026-05-27
00810166522847Expanding InnovationsEI46222026-05-27
00810166522854Expanding InnovationsEI46232026-05-27
00810166520331X-PACEI30602026-05-01
00810166520454X-PACEI46002026-05-01
00810166520461X-PACEI46012026-05-01
00810166520478X-PACEI46022026-05-01
00810166520515X-PACEI30632026-05-01
00810166520522X-PACEI30642026-05-01
00810166520553X-PACEI24682026-05-01
00810166520560X-PACEI24692026-05-01
00810166520577X-PACEI24702026-05-01
00810166521048X-PACEI26102026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653159014208CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014215CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014222CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014239CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23