OR Specific

Primary DI
10841027102967
Brand
OR Specific
Company
PEDIGO PRODUCTS, INC.
Model
419-HD-S
Device description
Drape, Heavy Duty, For 5' Big Case Back Table Model 428 Series. Case of 10. Sterile.- Each
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841027102967PackageGS110In Commercial Distribution
00841027102960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084102710296710841027102967
00841027102960008410271029608410271029600841027102960

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008301772
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841027105749Pedigo Products, Inc.EC1350BL-BI2026-07-24
00841027105725Pedigo Products, Inc.EC350L-1L-CA2026-07-12
00841027105695Pedigo Products, Inc.P-1080-8-RED2026-06-26
00841027104766Pedigo Products, Inc.EC250L-2BA-MED2026-06-02
00841027104728Pedigo Products, Inc.EC1350BL-1LF-MED2026-05-12
00841027104735Pedigo Products, Inc.EC550BL-18-220-230V-TYPE-L2026-05-12
00841027104742Pedigo Products, Inc.DC250-220-230V-TYPE-I2026-05-12
00841027104759Pedigo Products, Inc.EC1350BL-LH2026-05-12
00841027103233Pedigo Products, Inc.P-1083-82026-01-08
00841027103240Pedigo Products, Inc.P-72022026-01-08
00841027102960OR Specific419-HD-S2025-12-08
00841027101604Pedigo Products, Inc.DC250L-1L-CA2025-12-08
00841027102298Pedigo Products, Inc.IVNOW2-EPM-TYPE-J2025-12-08
00841027102311Pedigo Products, Inc.IVNOW2-EPM-TYPE-N2025-12-08
00841027102328Pedigo Products, Inc.IVNOW2-MED2025-12-08
00841027102335Pedigo Products, Inc.IVNOW32025-12-08
00841027102342Pedigo Products, Inc.IVNOW3-EPM-TYPE-B2025-12-08
00841027102359Pedigo Products, Inc.IVNOW3-EPM-TYPE-DM2025-12-08
00841027102366Pedigo Products, Inc.IVNOW3-EPM-TYPE-EF2025-12-08
00841027102373Pedigo Products, Inc.IVNOW3-EPM-TYPE-G2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538999HalyardMEDICAL ACTION INDUSTRIES INC.PUI2026-09-24
10850091824002AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10850091824019AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10197344220083MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
10197344220090MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
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