FDA.reportPublic FDA data

PILLING

Primary DI
24026704515800
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN005199
Catalog number
342006
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704515804PackageGS110In Commercial Distribution
24026704515800PrimaryGS10
04026704515806Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4402670451580444026704515804
2402670451580024026704515800
04026704515806040267045158064026704515806

GMDN Terms#

Term, Definition table
TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
8
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810136433593OptimalMTP®Forma Medical, Inc.HRS2026-10-16
00810136433609OptimalMTP®Forma Medical, Inc.HRS2026-10-16
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08809986482815CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482822CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482839CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482846CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482853CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482860CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482778CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482785CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482716CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482723CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482730CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482747CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482754CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482761CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06