FDA.reportPublic FDA data

Pedigo Products, Inc.

Primary DI
00841027100010
Brand
Pedigo Products, Inc.
Company
PEDIGO PRODUCTS, INC.
Model
CDS-3060-DD
Catalog number
CDS-3060-DD
Device description
Disposable Drape, sterile, for a CDS-3060 5 foot table
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
10841027100017PackageGS112In Commercial Distribution
00841027100010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084102710001710841027100017
00841027100010008410271000108410271000100841027100010

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-822-3501custserv@pedigo-usa.com

Regulatory Flags#

DUNS number
008301772
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841027102380Pedigo Products, Inc.IVNOW3-EPM-TYPE-H2025-12-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
B376KB100DAB0Drape KB100 SeriesKent Imaging IncPUI2026-07-21
10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
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