FDA.reportPublic FDA data

OR Specific

Primary DI
00841027102960
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
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.

Regulatory Flags#

DUNS number
008301772
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00841027102380Pedigo Products, Inc.IVNOW3-EPM-TYPE-H2025-12-08
00841027102397Pedigo Products, Inc.IVNOW3-EPM-TYPE-I2025-12-08
00841027102403Pedigo Products, Inc.IVNOW3-EPM-TYPE-J2025-12-08
00841027102410Pedigo Products, Inc.IVNOW3-EPM-TYPE-L2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLCPUI2026-06-02
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28