FDA.report

PILLING

Primary DI
54026704801744
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN020551
Catalog number
P25160
Device description
DESMARRES LID RET SZ 0 11MM
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNIRetractor, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54026704801744Direct MarkingGS10
14026704801746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5402670480174454026704801744
1402670480174614026704801746

GMDN Terms

TermDefinition
Fluorescent-hydrogel subcutaneous oxygen sensorA non-active implantable hydrogel device designed to be injected into subcutaneous tissue (typically in the limbs) to sense and convey tissue oxygen levels by emitting fluorescent (phosphorescent) signals when excited by an external light source, whereby the signals produced, measured by an external optical reader, correlate with oxygen levels.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
002348191
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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