FDA.report

Pro-X1

Primary DI
05397283000106
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XNI-011
Device description
Pro-X1 K-Wire ruler
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05397283000106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05397283000106053972830001065397283000106

GMDN Terms

TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
119116284
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
05397283000007Pro-X1XNI-100-X2024-08-27
05397283000014Pro-X1XNI-200-Y2024-08-27
05397283000021Pro-X1XNI-0022024-08-27
05397283000038Pro-X1XNI-0032024-08-27
05397283000045Pro-X1XNI-0042024-08-27
05397283000052Pro-X1XNI-0052024-08-27
05397283000069Pro-X1XNI-0062024-08-27
05397283000076Pro-X1XNI-0072024-08-27
05397283000083Pro-X1XNI-0082024-08-27
05397283000090Pro-X1XNI-0092024-08-27
05397283000113Pro-X1XNI-0122024-08-27
05397283000120Pro-X1XNI-0142024-08-27
05397283000137Pro-X1XNI-0152024-08-27
05397283000144Pro-X1XNI-0162024-08-27
05397283000168Pro-X1XNI-0182024-08-27
05397283000175Pro-X1XNI-0192024-08-27
05397283000182Pro-X1XNI-0202024-08-27
05397283000199Pro-X1XNI-0212024-08-27
05397283000205Pro-X1XNI-0222024-08-27
05397283000212Pro-X1XNI-0232024-08-27

Other Devices Sharing Product Codes

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00887868150876Affixus®Zimmer, Inc.HSB2026-03-20
00887868150333Affixus®Zimmer, Inc.HSB2026-03-19
00887868150340Affixus®Zimmer, Inc.HSB2026-03-19
00887868150357Affixus®Zimmer, Inc.HSB2026-03-19
00887868150364Affixus®Zimmer, Inc.HSB2026-03-19
00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
00887868150579Affixus®Zimmer, Inc.HSB2026-03-19
00887868150586Affixus®Zimmer, Inc.HSB2026-03-19
00887868150593Affixus®Zimmer, Inc.HSB2026-03-19
00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16