| Device Type ID | 2597 |
| Device Name | Wrap, Sterilization |
| Regulation Description | Sterilization Wrap. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FRG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2597 |
| Device | Wrap, Sterilization |
| Product Code | FRG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sterilization Wrap. |
| CFR Regulation Number | 880.6850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED STERILIZATION PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AHLSTROM NONWOVENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AMERICAN ORTHODONTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANDERSEN STERILIZERS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CARDINAL HEALTH 200, LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CASE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GS MEDICAL PACKAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HALYARD HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KIMBERLY-CLARK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KIMBERLY-CLARK CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SAFE SECURE PACKAGING CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIGMA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIGMA MEDICAL SUPPLIES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STANDARD TEXTILE CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SYMMETRY MEDICAL INC- MANCHESTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U&U MEDICAL TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Disinfection Or Sterilization Issue | 10 |
Problem With Sterilization | 7 |
Device Operates Differently Than Expected | 3 |
Material Integrity Problem | 3 |
Residue After Decontamination | 3 |
Hole In Material | 3 |
Material Fragmentation | 2 |
Device Issue | 2 |
Material Puncture / Hole | 2 |
Failure To Adhere Or Bond | 2 |
Contamination During Use | 2 |
Product Quality Problem | 2 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Metal Shedding Debris | 1 |
Appropriate Term/Code Not Available | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Out-Of-Box Failure | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Unintended Movement | 1 |
Thermal Decomposition Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 52 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Advanced Sterilization Products | II | Mar-23-2015 |
| 2 | Steris Corporation | II | Feb-27-2018 |