FDA.report

Key Surgical K-Wire and Pin Covers

Primary DI
10849771004094
Brand
Key Surgical K-Wire and Pin Covers
Company
KEY SURGICAL, INC.
Model
C-054
Device description
K-Wire Covers, Sterile, Red, .054" / 1.4mm, 2/pkg
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849771004094PackageGS112In Commercial Distribution
00849771004097PrimaryGS10
00849771043621Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977100409410849771004094
00849771004097008497710040978497710040970849771004097
00849771043621008497710436218497710436210849771043621

GMDN Terms

TermDefinition
Surgical instrument guard, single-use, sterileA sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter0.054Inch

Sterilization Methods

Method

Contacts

PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags

DUNS number
604056226
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
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50849771050617NAK-Wire and Pin CoversC1092025-01-29
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