FDA.reportPublic FDA data

X-PAC

Primary DI
00850041805351
Brand
X-PAC
Company
EXPANDING INNOVATIONS, INC.
Model
EI3047
Device description
X-PAC Lateral General Implant Caddy
Published
2023-07-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K223174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223174000X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.2023-02-14MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041805351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041805351008500418053518500418053510850041805351

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00810166521604X-PACEI26152026-07-30
00810166521611X-PACEI26162026-07-30
00810166521628X-PACEI24672026-07-30
00810166521703X-PACEI26242026-07-30
00810166521765X-PACEI26222026-07-30
00810166523004X-PACEI24802026-07-30
00810166523011X-PACEI24792026-07-30
00810166523028X-PACEI2477EI24512026-07-30
00850001720830X-PACEI30342026-07-30
00850041805863X-PACEI26082026-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640092166INSTRUSAFESummit Medical, Inc.KCT2026-08-07
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00385640092197INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092203INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092210INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092227INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092234INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092241INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092258INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092265INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092272INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092289INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092296INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092302INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092319INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092326INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092333INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092340INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092357INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092364INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092371INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092388INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092395INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092401INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092418INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092425INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092432INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092449INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07