FDA.reportPublic FDA data

PRO-PAKS®️

Primary DI
10810003220223
Brand
PRO-PAKS®️
Company
MICROSPECIALITIES, INC.
Model
PD1176
Catalog number
PD1176
Device description
Drape Ophthalmic, incise, Plastic, w/ 3-sided gutter Pouch, Clear Plastic. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our drapes. 10 per bag.
Published
2018-10-30
Public version status
New
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
HMTDrape, Patient, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810003220227PackageGS110In Commercial Distribution
10810003220223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081000322022730810003220227
1081000322022310810003220223

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical drapeA protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Inch
Length203.2Centimeter
Width65Inch
Width165.1Centimeter

Contacts#

Phone, Email table
PhoneEmail
203-874-1832xx@xx.xx

Regulatory Flags#

DUNS number
013469890
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810003224757NAMK8510LSKMK8510LSK2026-04-29
10810003224764NAMK8511CB2026-04-29
10810003224771NA3001352026-04-29
10810003224788NA3001602026-04-29
10810003224795NA300202026-04-29
10810003224801NAMK85072026-04-29
10810003224818NAMK85082026-04-29
10810003223545Comfortear™24-200824-20082019-01-03
10810003223552Comfortear™24-200724-20072019-01-03
10810003223569Comfortear™24-200624-20062019-01-03
10810003223576Comfortear™24-200524-20052019-01-03
10810003223583Comfortear™24-200424-20042019-01-03
10810003223590Comfortear™32-200832-20082019-01-03
10810003223606Comfortear™32-200732-20072019-01-03
10810003223613Comfortear™32-200632-20062019-01-03
10810003223620Comfortear™32-200532-20052019-01-03
10810003223637Comfortear™32-200432-20042019-01-03
10810003223644Comfortear™60-601060-60102019-01-03
10810003224443Pro-Paks1002PL1002PL2023-09-02
10810003224450Pro-Paks2002PL2002PL2023-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344179685MEDLINEMEDLINE INDUSTRIES, INC.HMT2026-02-12
10192253066630CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066647CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066661CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066678CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066685CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066638CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066645CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066669CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066676CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066683CONVERTORSCardinal Health 200, LLCHMT2025-06-18
00380650003904UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650003911UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650004185UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003901UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003918UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650004182UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650003881ALCONAlcon Laboratories, Inc.HMT2024-07-02
10380650003888ALCONAlcon Laboratories, Inc.HMT2024-07-02
00326053120510Regard™Resource Optimization & Innovation, L.L.C.HMT2023-12-20
00326053120596Regard™Resource Optimization & Innovation, L.L.C.HMT2023-12-20
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10326053120593Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
10326053120630Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
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