FDA.report

Key Surgical K-Wire and Pin Covers

Primary DI
10849771004162
Brand
Key Surgical K-Wire and Pin Covers
Company
KEY SURGICAL, INC.
Model
C-045
Device description
K-Wire Covers, Sterile, White, .045" / 1.1mm, 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
10849771004162PackageGS112In Commercial Distribution
00849771004165PrimaryGS10
00849771043607Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977100416210849771004162
00849771004165008497710041658497710041650849771004165
00849771043607008497710436078497710436070849771043607

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 Diameter0.043Inch
Lumen/Inner Diameter0.045Inch

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
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
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50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
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