FDA.reportPublic FDA data

PILLING

Primary DI
04026704417810
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004268
Catalog number
200328
Device description
SPONGE TONSIL EXTRA LARGE COTTON NONSTERILE 500/ BOX
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913302000DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIEDCarwild Corp.1992-07-23GDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704417814PackageGS1100In Commercial Distribution
04026704417810PrimaryGS10
14026704417817Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670441781424026704417814
04026704417810040267044178104026704417810
1402670441781714026704417817

GMDN Terms#

Term, Definition table
TermDefinition
Dissection spongeA sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length86Millimeter
Width58Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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10801902172508ARROWIPN917417CS-24306-E2022-11-29
10801902180268ARROWIPN917220AI-071212021-08-19
10801902180589ARROWIPN918510CS-12702-E2022-11-29
10801902180756ARROWIPN917232AI-071342021-08-11

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Primary DI, Brand, Company table
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