FDA.report

PILLING

Primary DI
24026704599404
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004236
Catalog number
200123
Device description
SPONGE NEURO STERILE STRING NON XRAY 1/2X3" 200/BOX
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications

CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704599404PackageGS1200In Commercial Distribution
04026704599400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670459940424026704599404
04026704599400040267045994004026704599400

GMDN Terms

TermDefinition
Neurosurgical spongeA sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.

Device Sizes

TypeValueUnit
Length0.5Inch
Width3Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

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

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